Trial · NCT02657369
A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)
NCT02657369, Phase 2, Terminated, Eisai Inc.; results first posted 2019-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC). Trials, record NCT02657369. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02657369
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)
- NCT number
- NCT02657369
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Thyroid Carcinoma, Anaplastic
- Interventions
- Lenvatinib 24 mg
- First posted
- 2016-01-15
- Last updated
- 2019-10-15
- Other registries' IDs
- eudract:2015-001929-17
- Results first posted
- 2019-10-15
- Limitations and caveats
- The study was terminated since overall response rate was 3% (only 1 out of 33 participants had confirmed PR).
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | From the date of beginning of lenvatinib administration to the date of first documentation of disease progression or death, whichever occurred first (up to Month 27) | ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator review using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for target lesions. CR was defined as disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameters of target lesions, taking as reference the Baseline sum diameters. Confirmation of CR or PR was performed at least 28 days following the initial achievement of the response. |
| Secondary | Progression-free Survival (PFS) Rate | From the date of beginning of lenvatinib administration up to the date of first documentation of confirmed disease progression or death, whichever occurred first (up to Week 12) | Twelve-week PFS rate was the percentage of participants in the analysis population who remain alive and progression-free at 12 weeks. PFS was defined as the time from the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurred first. The Kaplan-Meier estimated rate method was used to estimate 12-week PFS, along with the corresponding 95% confidence interval (CI). Participants who were off study due to lost to follow up, withdrew consent, or study terminated by sponsor, had new anti-cancer treatment, had no baseline/post-baseline tumor assessments, or missed 2 or more visits prior to event were censored. |
| Secondary | Overall Survival (OS) Rate | From the date of beginning of lenvatinib administration up to date of death from any cause (up to Month 6) | Six-month OS rate was defined as the percentage of participants in the analysis population who are alive at 6 months. OS was defined as the time from the date of beginning of lenvatinib administration until date of death from any cause. The Kaplan-Meier estimated rate method was used to estimate six-month OS, along with the corresponding 95% CI. Participants with last known alive date as study terminated by sponsor were censored. |
| Secondary | Median PFS | From the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurred first (up to Month 27) | PFS was defined as the time from the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method. Participants who were off study due to lost to follow up, withdrew consent, or study terminated by sponsor, had new anti-cancer treatment, had no baseline/post-baseline tumor assessments, or missed 2 or more visits prior to event were censored. |
| Secondary | Median OS | From the date of beginning of lenvatinib administration up to date of death from any cause (up to Month 27) | OS was defined as the time from the date of beginning of lenvatinib administration until date of death from any cause. Median OS was estimated using the Kaplan-Meier method. Participants with last known alive date as study terminated by sponsor were censored. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | From the date of beginning of lenvatinib administration to the date of first documentation of disease progression or death, whichever occurred first (up to Month 27) | The evaluable analysis set included all participants with histological diagnosis of ATC that was confirmed by central pathology review and who received at least one dose of lenvatinib. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) Rate | From the date of beginning of lenvatinib administration up to the date of first documentation of confirmed disease progression or death, whichever occurred first (up to Week 12) | The full analysis set included all participants who received at least one dose of lenvatinib. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) Rate | From the date of beginning of lenvatinib administration up to date of death from any cause (up to Month 6) | The full analysis set included all participants who received at least one dose of lenvatinib. | percentage of participants | NUMBER |
| SECONDARY | Median PFS | From the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurred first (up to Month 27) | The full analysis set included all participants who received at least one dose of lenvatinib. | months | MEDIAN |
| SECONDARY | Median OS | From the date of beginning of lenvatinib administration up to date of death from any cause (up to Month 27) | The full analysis set included all participants who received at least one dose of lenvatinib. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Lenvatinib 24 mg | 3.0 | 95% Confidence Interval 0.1 to 15.8 | percentage of participants | |
| Progression-free Survival (PFS) Rate | Lenvatinib 24 mg | 36.4 | 95% Confidence Interval 20.6 to 52.3 | percentage of participants | |
| Overall Survival (OS) Rate | Lenvatinib 24 mg | 41.2 | 95% Confidence Interval 24.8 to 56.9 | percentage of participants | |
| Median PFS | Lenvatinib 24 mg | 2.6 | 95% Confidence Interval 1.4 to 2.8 | months | |
| Median OS | Lenvatinib 24 mg | 3.2 | 95% Confidence Interval 2.8 to 8.2 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenvatinib 24 mg | 34 | |
| Overall Study | COMPLETED | Lenvatinib 24 mg | 0 | |
| Overall Study | NOT COMPLETED | Lenvatinib 24 mg | 34 |
Source ClinicalTrials.gov
Adverse events233
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bloody discharge | Vascular disorders | Lenvatinib | 1 | 34 | 1 |
| other | Hypertension | Vascular disorders | Lenvatinib | 18 | 34 | 34 |
| other | Hypotension | Vascular disorders | Lenvatinib | 2 | 34 | 2 |
| other | Inferior vena cava dilatation | Vascular disorders | Lenvatinib | 1 | 34 | 1 |
| other | Vena cava thrombosis | Vascular disorders | Lenvatinib | 1 | 34 | 1 |
| other | Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Lenvatinib | 1 | 34 | 3 |
| other | Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Lenvatinib | 1 | 34 | 1 |
| other | Contrast media reaction | Immune system disorders | Lenvatinib | 1 | 34 | 1 |
| other | Asthenia | General disorders | Lenvatinib | 5 | 34 | 8 |
| other | Cyst | General disorders | Lenvatinib | 1 | 34 | 1 |
1 to 10 of 233Source ClinicalTrials.gov
See all 233 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenvatinib | 27 | 34 |
| Total, other adverse events | Lenvatinib | 32 | 34 |
| Total, serious adverse events | Lenvatinib | 25 | 34 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02657369
GET https://conductscience.org/api/trials/v1/NCT02657369/events?page=2